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Penguin Cold Caps in the Prevention of Hair Loss in Breast Cancer Patients

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Penguin Cold Caps
Sponsored by
Providence Health & Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Breast Cancer, Alopecia, Hair Loss, Scalp Cooling, Penguin Cold Caps

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At least ≥ 18 years of age
  • Diagnosis of stage I-III breast cancer for whom neoadjuvant or adjuvant cytotoxic chemotherapy (ACT/HP, TCH/P, TC, or T/H) is planned.
  • Willing and able to provide informed consent.
  • Availability of caretaker(s) to accompany participant and facilitate cold-cap placement/exchanges using the recommended technique.
  • Women of childbearing potential must use acceptable measures to avoid becoming pregnant during study period and for 30 days after last dose of chemotherapy.

Exclusion Criteria:

  • Pre-existing alopecia (Dean's scale ≥ 1)
  • Another malignancy that required active treatment with systemic chemotherapy within 2 years of study recruitment.
  • Prior radiotherapy treatment involving head.
  • Pre-existing chronic severe headaches or migraines.
  • Skin conditions that in the opinion of PI would be at risk of worsening with study.
  • Cold sensitivity or cold agglutinin disease
  • Cryoglobulinemia
  • Cryofibrogenemia
  • History of current evidence of any condition, therapy or abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, such that trial participation is not in the best interest of the subject.

Sites / Locations

  • Providence Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Penguin Cold Caps

Arm Description

Penguin Cold-cap therapy will commence at least 50 minutes prior to chemotherapy infusion, and will continue for 4 hours following completion of chemotherapy.

Outcomes

Primary Outcome Measures

Deans Alopecia Scale
Number of patients who score from 0-2 on Deans Alopecia Scale

Secondary Outcome Measures

Was it Worth it Questionnaire
Number of patients reporting positive or beneficial effects of Cold Cap therapy on the Was it Worth it Questionnaire.
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30
Number of patients reporting positive or beneficial effects of Cold Cap therapy on the EORTC QLQ-C30
Body Image Scale Questionnaire
These outcomes will be reported as the proportion of patients (and confidence intervals) reporting the study cold-cap therapy as positive and beneficial on the Body Image Scale Questionnaire
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
The proportion of patients (and confidence intervals) with grade 1 or 2 alopecia according to CTCAE rating scale

Full Information

First Posted
September 18, 2017
Last Updated
September 14, 2020
Sponsor
Providence Health & Services
Collaborators
Medical Specialties of California
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1. Study Identification

Unique Protocol Identification Number
NCT03289364
Brief Title
Penguin Cold Caps in the Prevention of Hair Loss in Breast Cancer Patients
Official Title
A Phase 2 Study to Assess the Safety and Efficacy of Scalp Cooling Using PenguinTM Cold Caps for the Prevention or Reduction of Chemotherapy-induced Alopecia in Stage I-III Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 24, 2017 (Actual)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Providence Health & Services
Collaborators
Medical Specialties of California

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this study is to estimate the efficacy of Penguin cold caps in preventing or reducing hair loss in patients receiving (neo)adjuvant chemotherapy (one of four common regimens) for early stage breast cancer.
Detailed Description
This will be a phase II prospective, open label, non-randomized study conducted to determine the safety and efficacy of Penguin TM cold cap system in preventing or reducing chemotherapy-induced alopecia in patients with early stage breast cancer undergoing chemotherapy. Eligible subjects will be enrolled to one of 4 study arms (Table 5) determined by type of chemotherapy. Subjects will have early stage breast cancer of any receptor subtype, for which standard of care includes chemotherapy. Eligible subjects will be enrolled at Providence Portland Medical Center (PPMC) and Providence St. Vincent Medical Center (PSVMC). The PenguinTM cold cap therapy will be administered to all enrolled subjects according to the dosing schedule specified by the study arms. PenguinTM cold caps is a portable scalp cooling system which uses gel-filled cold caps that are cooled on dry ice and exchanged every 30 minutes in order to maintain optimum temperature. Its unique crylon gel formula is specifically created to maintain cold temperatures for much longer periods of time than other conventional cooling gels and foams. No scalp preparation is required before use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Alopecia, Hair Loss, Scalp Cooling, Penguin Cold Caps

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients will use the Penguin Cold Caps during prior to, during, and after chemotherapy administration. Cold-cap therapy will commence at least 50 minutes prior to infusion, and will continue for 4 hours following completion of chemotherapy.
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Penguin Cold Caps
Arm Type
Experimental
Arm Description
Penguin Cold-cap therapy will commence at least 50 minutes prior to chemotherapy infusion, and will continue for 4 hours following completion of chemotherapy.
Intervention Type
Device
Intervention Name(s)
Penguin Cold Caps
Intervention Description
Patients will wear Penguin Cold Cap scalp cooling device prior to each chemotherapy administration, during administration, and for four hours following administration.
Primary Outcome Measure Information:
Title
Deans Alopecia Scale
Description
Number of patients who score from 0-2 on Deans Alopecia Scale
Time Frame
30 days post chemotherapy treatment
Secondary Outcome Measure Information:
Title
Was it Worth it Questionnaire
Description
Number of patients reporting positive or beneficial effects of Cold Cap therapy on the Was it Worth it Questionnaire.
Time Frame
30 days post chemotherapy treatment
Title
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30
Description
Number of patients reporting positive or beneficial effects of Cold Cap therapy on the EORTC QLQ-C30
Time Frame
30 days post chemotherapy treatment
Title
Body Image Scale Questionnaire
Description
These outcomes will be reported as the proportion of patients (and confidence intervals) reporting the study cold-cap therapy as positive and beneficial on the Body Image Scale Questionnaire
Time Frame
30 days post chemotherapy treatment
Title
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Description
The proportion of patients (and confidence intervals) with grade 1 or 2 alopecia according to CTCAE rating scale
Time Frame
30 days post chemotherapy treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least ≥ 18 years of age Diagnosis of stage I-III breast cancer for whom neoadjuvant or adjuvant cytotoxic chemotherapy (ACT/HP, TCH/P, TC, or T/H) is planned. Willing and able to provide informed consent. Availability of caretaker(s) to accompany participant and facilitate cold-cap placement/exchanges using the recommended technique. Women of childbearing potential must use acceptable measures to avoid becoming pregnant during study period and for 30 days after last dose of chemotherapy. Exclusion Criteria: Pre-existing alopecia (Dean's scale ≥ 1) Another malignancy that required active treatment with systemic chemotherapy within 2 years of study recruitment. Prior radiotherapy treatment involving head. Pre-existing chronic severe headaches or migraines. Skin conditions that in the opinion of PI would be at risk of worsening with study. Cold sensitivity or cold agglutinin disease Cryoglobulinemia Cryofibrogenemia History of current evidence of any condition, therapy or abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, such that trial participation is not in the best interest of the subject.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Page, MD
Organizational Affiliation
Providence Health & Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence Cancer Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Penguin Cold Caps in the Prevention of Hair Loss in Breast Cancer Patients

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